Medical device with lack-of-readiness alarm

ABSTRACT

A medical device for caring for a patient includes a patient utility for measuring a patient parameter or administering a therapy to the patient and an alarm system that has a receiver to accept status information about the medical device. A use detector of the alarm system is structured to determine when the medical device is being prepared for use and a status detector of the alarm system is adapted to determine from the status information that the medical device is in a ready state. The alarm system further includes an alarm that is activated when the medical device is both being prepared for use and not in the ready state. This description also includes methods of generating an alarm when the medical device is both being prepared for use and not in the ready state.

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This patent application is a continuation of co-pending U.S. patentapplication Ser. No. 15/194,296, filed on Jun. 27, 2016, which willissue on Feb. 5, 2019, as U.S. Pat. No. 10,195,451, entitled MEDICALDEVICE WITH LACK-OF-READINESS ALARM, which is a division application ofU.S. patent application Ser. No. 13/662,292, filed on Oct. 26, 2012, nowU.S. Pat. No. 9,375,584, entitled

MEDICAL DEVICE WITH LACK-OF-READINESS ALARM, which claims the benefit toU.S. Provisional Patent Application Ser. No. 61/650,406, filed on May22, 2012, entitled LACK-OF-READINESS ALARM FOR MEDICAL DEVICE ABOUT TOBE USED, the disclosures of which are hereby incorporated by referencefor all purposes.

FIELD

This invention generally relates to medical devices such as externaldefibrillators.

BACKGROUND

In humans, the heart beats to sustain life. In normal operation, itpumps blood through the various parts of the body. More particularly,the various chamber of the heart contract and expand in a periodic andcoordinated fashion, which causes the blood to be pumped regularly. Morespecifically, the right atrium sends deoxygenated blood into the rightventricle. The right ventricle pumps the blood to the lungs, where itbecomes oxygenated, and from where it returns to the left atrium. Theleft atrium pumps the oxygenated blood to the left ventricle. The leftventricle, then, expels the blood, forcing it to circulate to thevarious parts of the body.

The heart chambers pump because of the heart's electrical controlsystem. More particularly, the sinoatrial (SA) node generates anelectrical impulse, which generates further electrical signals. Thesefurther signals cause the above-described contractions of the variouschambers in the heart, in the correct sequence. The electrical patterncreated by the sinoatrial (SA) node is called a sinus rhythm.

Sometimes, however, the electrical control system of the heartmalfunctions, which can cause the heart to beat irregularly, or not atall. The cardiac rhythm is then generally called an arrhythmia.Arrhythmias may be caused by electrical activity from locations in theheart other than the SA node. Some types of arrhythmia may result ininadequate blood flow, thus reducing the amount of blood pumped to thevarious parts of the body. Some arrhythmias may even result in a SuddenCardiac Arrest (SCA). In a SCA, the heart fails to pump bloodeffectively, and, if not treated, death can occur. In fact, it isestimated that SCA results in more than 250,000 deaths per year in theUnited States alone. Further, a SCA may result from a condition otherthan an arrhythmia.

One type of arrhythmia associated with SCA is known as VentricularFibrillation (VF). VF is a type of malfunction where the ventricles makerapid, uncoordinated movements, instead of the normal contractions. Whenthat happens, the heart does not pump enough blood to deliver enoughoxygen to the vital organs. The person's condition will deterioraterapidly and, if not reversed in time, they will die soon, e.g. withinten minutes.

Ventricular Fibrillation can often be reversed using a life-savingdevice called a defibrillator. A defibrillator, if applied properly, canadminister an electrical shock to the heart. The shock may terminate theVF, thus giving the heart the opportunity to resume pumping blood. If VFis not terminated, the shock may be repeated, often at escalatingenergies.

A challenge with defibrillation is that the electrical shock must beadministered very soon after the onset of VF. There is not much time:the survival rate of persons suffering from VF decreases by about 10%for each minute the administration of a defibrillation shock is delayed.After about 10 minutes the rate of survival for SCA victims averagesless than 2%.

The challenge of defibrillating early after the onset of VF is being metin a number of ways. First, for some people who are considered to be ata higher risk of VF or other heart arrhythmias, an ImplantableCardioverter Defibrillator (ICD) can be implanted surgically. An ICD canmonitor the person's heart, and administer an electrical shock asneeded. As such, an ICD reduces the need to have the higher-risk personbe monitored constantly by medical personnel.

Regardless, VF can occur unpredictably, even to a person who is notconsidered at risk. As such, VF can be experienced by many people wholack the benefit of ICD therapy. When VF occurs to a person who does nothave an ICD, they collapse, because blood flow has stopped. They shouldreceive therapy quickly.

For a VF victim without an ICD, a different type of defibrillator can beused, which is called an external defibrillator. External defibrillatorshave been made portable, so they can be brought to a potential VF victimquickly enough to revive them.

During VF, the person's condition deteriorates, because the blood is notflowing to the brain, heart, lungs, and other organs. Blood flow must berestored, if resuscitation attempts are to be successful.

Cardiopulmonary Resuscitation (CPR) is one method of forcing blood flowin a person experiencing cardiac arrest. In addition, CPR is the primaryrecommended treatment for some patients with some kinds of non-VFcardiac arrest, such as asystole and pulseless electrical activity(PEA). CPR is a combination of techniques that include chestcompressions to force blood circulation, and rescue breathing to forcerespiration.

Properly administered CPR provides oxygenated blood to critical organsof a person in cardiac arrest, thereby minimizing the deterioration thatwould otherwise occur. As such, CPR can be beneficial for personsexperiencing VF, because it slows the deterioration that would otherwiseoccur while a defibrillator is being retrieved. Indeed, for patientswith an extended down-time, survival rates are higher if CPR isadministered prior to defibrillation.

Advanced medical devices can actually coach a rescuer who performs CPR.For example, a medical device can issue instructions, and even prompts,for the rescuer to perform CPR more effectively.

Many medical devices include or use components that are subject toageing or expiration. For example, many defibrillators use gelled padsthat dry over time and become unusable. Additionally, portabledefibrillators include batteries to generate shock signals and operatethe defibrillator, and such batteries may be unable to store adequatecharge due to ageing. In other cases the batteries may be physicallysound but merely store a charge that is below that necessary to properlyoperate the defibrillator. In such instances, a rescuer or other personmay take a medical device into a rescue situation when the medicaldevice is not in proper condition for use due to the battery not beingcharged, or consumable or other components not being ready for use.

Embodiments of the invention address these and other limitations of theprior art.

BRIEF SUMMARY

The present description gives instances of medical devices, systems, andmethods, the use of which may help overcome problems and limitations ofthe prior art. In one embodiment, a medical device includes a patientutility for measuring a patient parameter or administering a therapy tothe patient as well as an alarm system. The alarm system includes areceiver to accept status information about the medical device, a usedetector structured to determine when the medical device is beingprepared for use, a status detector adapted to determine from the statusinformation that the medical device is in a ready state, and an alarmthat is activated when the medical device is both being prepared for useand not in the ready state. The alarm may be user configurable.

Other embodiments include methods for alerting a user of a medicaldevice to a state of readiness of the medical device. Methods mayinclude sensing that the medical device is about to be used andassessing a value for a readiness state of the medical device. When itis determined that the medical device is about to be used and theassessed readiness state value is below a threshold level, then an alarmis generated that alerts the user to the status of the medical device.

An advantage over the prior art is that it reduces or eliminates thepossibility of a rescuer bringing a medical device to a rescue scenethat may not function correctly or to its full capabilities.

These and other features and advantages of this description will becomemore readily apparent from the following Detailed Description, whichproceeds with reference to the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of a scene where an external defibrillator is usedto save the life of a person according to embodiments.

FIG. 2 is a table listing two main types of the external defibrillatorshown in FIG. 1, and who they might be used by.

FIG. 3 is a diagram showing components of an external defibrillatormedical device, such as the one shown in FIG. 1, which includes an alarmsystem according to embodiments.

FIG. 4 is a functional block diagram of an alarm system component of themedical device of FIG. 3 according to embodiments.

FIG. 5 is a block diagram of an example simple user interface for thealarm system of FIG. 4 according to embodiments.

FIG. 6 is a block diagram of an example user interface for the alarmsystem of FIG. 4 according to embodiments.

FIG. 7 is a block diagram illustrating example components that may beused to construct the alarm system of FIG. 4 according to embodiments.

FIG. 8 is a flowchart illustrating example methods according toembodiments.

DETAILED DESCRIPTION

FIG. 1 is a diagram of a defibrillation scene. A person 82 is lying ontheir back. Person 82 could be a patient in a hospital, or someone foundunconscious, and then turned to be on their back. Person 82 isexperiencing a condition in their heart 85, which could be VentricularFibrillation (VF).

A portable external defibrillator 100 has been brought close to person82. At least two defibrillation electrodes 104, 108 are usually providedwith external defibrillator 100, and are sometimes called electrodes104, 108. Electrodes 104, 108 are coupled with external defibrillator100 via respective electrode leads 105, 109. A rescuer (not shown) hasattached electrodes 104, 108 to the skin of person 82. Defibrillator 100is administering, via electrodes 104, 108, a brief, strong electricpulse 111 through the body of person 82. Pulse 111, also known as adefibrillation shock, goes also through heart 85, in an attempt torestart it, for saving the life of person 82.

Defibrillator 100 can be one of different types, each with differentsets of features and capabilities. The set of capabilities ofdefibrillator 100 is determined by planning who would use it, and whattraining they would be likely to have. Examples are now described.

FIG. 2 is a table listing two main types of external defibrillators, andwho they are primarily intended to be used by. A first type ofdefibrillator 100 is generally called a defibrillator-monitor, becauseit is typically formed as a single unit in combination with a patientmonitor. A defibrillator-monitor is sometimes calledmonitor-defibrillator. A defibrillator-monitor is intended to be used bypersons in the medical professions, such as doctors, nurses, paramedics,emergency medical technicians, etc. Such a defibrillator-monitor isintended to be used in a pre-hospital or hospital scenario.

As a defibrillator, the device can be one of different varieties, oreven versatile enough to be able to switch among different modes thatindividually correspond to the varieties. One variety is that of anautomated defibrillator, which can determine whether a shock is neededand, if so, charge to a predetermined energy level and instruct the userto administer the shock. Another variety is that of a manualdefibrillator, where the user determines the need and controlsadministering the shock.

As a patient monitor, the device has features additional to what isminimally needed for mere operation as a defibrillator. These featurescan be for monitoring physiological indicators of a person in anemergency scenario. These physiological indicators are typicallymonitored as signals. For example, these signals can include a person'sfull ECG (electrocardiogram) signals, or impedance between twoelectrodes. Additionally, these signals can be about the person'stemperature, non-invasive blood pressure (NIBP), arterial oxygensaturation/pulse oximetry (SpO2), the concentration or partial pressureof carbon dioxide in the respiratory gases, which is also known ascapnography, and so on. These signals can be further stored and/ortransmitted as patient data.

A second type of external defibrillator 100 is generally called an AED,which stands for “Automated External Defibrillator”. An AED typicallymakes the shock/no shock determination by itself, automatically. Indeed,it can sense enough physiological conditions of the person 82 via onlythe shown defibrillation electrodes 104, 108 of FIG. 1. In its presentembodiments, an AED can either administer the shock automatically, orinstruct the user to do so, e.g. by pushing a button. Being of a muchsimpler construction, an AED typically costs much less than adefibrillator-monitor. As such, it makes sense for a hospital, forexample, to deploy AEDs at its various floors, in case the moreexpensive defibrillator-monitor is more critically being deployed at anIntensive Care Unit, and so on.

AEDs, however, can also be used by people who are not in the medicalprofession. More particularly, an AED can be used by many professionalfirst responders, such as policemen, firemen, etc. Even a person withonly first-aid training can use one. And AEDs increasingly can supplyinstructions to whoever is using them.

AEDs are thus particularly useful, because it is so critical to respondquickly, when a person suffers from VF. Indeed, the people who willfirst reach the VF sufferer may not be in the medical professions.

Increasing awareness has resulted in AEDs being deployed in public orsemi-public spaces, so that even a member of the public can use one, ifthey have obtained first aid and CPR/AED training on their owninitiative. This way, defibrillation can be administered soon enoughafter the onset of VF, to hopefully be effective in rescuing the person.

There are additional types of external defibrillators, which are notlisted in FIG. 2. For example, a hybrid defibrillator can have aspectsof an AED, and also of a defibrillator-monitor. A usual such aspect isadditional ECG monitoring capability. FIG. 3 is a diagram showingcomponents of an external defibrillator 300 made according toembodiments. These components can be, for example, in externaldefibrillator 100 of FIG. 1. Plus, these components of FIG. 3 can beprovided in a housing 301, which is also known as casing 301.

External defibrillator 300 is intended for use by a user 380, who wouldbe the rescuer. Defibrillator 300 typically includes a defibrillationport 310, such as a socket in housing 301. Defibrillation port 310includes nodes 314, 318. Defibrillation electrodes 304, 308, which canbe similar to electrodes 104, 108, can be plugged in defibrillation port310, so as to make electrical contact with nodes 314, 318, respectively.It is also possible that electrodes can be connected continuously todefibrillation port 310, etc. Either way, defibrillation port 310 can beused for guiding via electrodes to person 82 an electrical charge thathas been stored in defibrillator 300, as will be seen later in thisdocument.

If defibrillator 300 is actually a defibrillator-monitor, as wasdescribed with reference to FIG. 2, then it will typically also have anECG port 319 in housing 301, for plugging in ECG leads 309. ECG leads309 can help sense an ECG signal, e.g. a 12-lead signal, or from adifferent number of leads. Moreover, a defibrillator-monitor could haveadditional ports (not shown), and another component 325 for the abovedescribed additional features, such as patient signals.

Defibrillator 300 also includes a measurement circuit 320. Measurementcircuit 320 receives physiological signals from ECG port 319, and alsofrom other ports, if provided. These physiological signals are sensed,and information about them is rendered by circuit 320 as data, or othersignals, etc.

If defibrillator 300 is actually an AED, it may lack ECG port 319.Measurement circuit 320 can obtain physiological signals through nodes314, 318 instead, when defibrillation electrodes 304, 308 are attachedto person 82. In these cases, a person's

ECG signal can be sensed as a voltage difference between electrodes 304,308. Plus, impedance between electrodes 304, 308 can be sensed fordetecting, among other things, whether these electrodes 304, 308 havebeen inadvertently disconnected from the person.

Defibrillator 300 also includes a processor 330. Processor 330 may beimplemented in any number of ways. Such ways include, by way of exampleand not of limitation, digital and/or analog processors such asmicroprocessors and digital-signal processors (DSPs); controllers suchas microcontrollers; software running in a machine; programmablecircuits such as Field Programmable Gate Arrays (FPGAs),Field-Programmable Analog Arrays (FPAAs), Programmable Logic Devices(PLDs), Application Specific Integrated Circuits (ASICs), anycombination of one or more of these, and so on.

Processor 330 can be considered to have a number of modules. One suchmodule can be a detection module 332, which senses outputs ofmeasurement circuit 320. Detection module 332 can include a VF detector.Thus, the person's sensed ECG can be used to determine whether theperson is experiencing VF.

Another such module in processor 330 can be an advice module 334, whicharrives at advice based on outputs of detection module 332. Advicemodule 334 can include a Shock Advisory Algorithm, implement decisionrules, and so on. The advice can be to shock, to not shock, toadminister other forms of therapy, and so on. If the advice is to shock,some external defibrillator embodiments merely report that to the user,and prompt them to do it. Other embodiments further execute the advice,by administering the shock. If the advice is to administer CPR,defibrillator 300 may further issue prompts for it, and so on.

Processor 330 can include additional modules, such as module 336, forother functions.

In addition, the defibrillator 300 may include an alarm system 325 thatoperates to alert an operator if the defibrillator 300 is about to beused but is not ready for use, as described in detail below.

Defibrillator 300 optionally further includes a memory 338, which canwork together with processor 330. Memory 338 may be implemented in anynumber of ways.

Such ways include, by way of example and not of limitation, nonvolatilememories (NVM), read-only memories (ROM), random access memories (RAM),any combination of these, and so on. Memory 338, if provided, caninclude programs for processor 330, and so on. The programs can beoperational for the inherent needs of processor 330, and can alsoinclude protocols and ways that decisions can be made by advice module334. In addition, memory 338 can store prompts for user 380, etc.Moreover, memory 338 can store patient data.

Defibrillator 300 may also include a power source 340. To enableportability of defibrillator 300, power source 340 typically includes abattery. Such a battery is typically implemented as a battery pack,which can be rechargeable or not. Sometimes, a combination is used, ofrechargeable and non-rechargeable battery packs. Other embodiments ofpower source 340 can include AC power override, for where AC power willbe available, and so on. In some embodiments, power source 340 iscontrolled by processor 330.

Defibrillator 300 additionally includes an energy storage module 350.Module 350 is where some electrical energy is stored, when preparing itfor sudden discharge to administer a shock. Module 350 can be chargedfrom power source 340 to the right amount of energy, as controlled byprocessor 330. In typical implementations, module 350 includes one ormore capacitors 352, and so on.

Defibrillator 300 moreover includes a discharge circuit 355. Circuit 355can be controlled to permit the energy stored in module 350 to bedischarged to nodes 314, 318, and thus also to defibrillation electrodes304, 308. Circuit 355 can include one or more switches 357. Those can bemade in a number of ways, such as by an H-bridge, and so on.

Defibrillator 300 further includes a user interface 370 for user 380.User interface 370 can be made in any number of ways. For example,interface 370 may include a screen, to display what is detected andmeasured, provide visual feedback to the rescuer for their resuscitationattempts, and so on. Interface 370 may also include a speaker, to issuevoice prompts, etc. Interface 370 may additionally include variouscontrols, such as pushbuttons, keyboards, and so on. In addition,discharge circuit 355 can be controlled by processor 330, or directly byuser 380 via user interface 370, and so on.

Defibrillator 300 can optionally include other components. For example,a communication module 390 may be provided for communicating with othermachines. Such communication can be performed wirelessly, or via wire,or by infrared communication, and so on. This way, data can becommunicated, such as patient data, incident information, therapyattempted, CPR performance, and so on.

As has been mentioned, the present description is about devices, controlsystems, and methods for a medical device with a lack-of-readinessalarm.

Embodiments are now described in more detail.

FIG. 4 is a functional block diagram of an alarm system component of amedical device 400 according to embodiments. The medical device 400 maybe the same or similar to the defibrillator 300 of FIG. 3. The medicaldevice 400 is one for caring for a patient, for example the patient 82of FIG. 1. The medical device 400 includes a patient utility 404 formeasuring a patient parameter or administering a therapy to the patient82. The therapy may be defibrillation for example. The measuredparameters may include, for example, a person's full ECG(electrocardiogram) signals, or impedance between two electrodes.Additionally, these parameters may be signals about the person'stemperature, non-invasive blood pressure (NIBP), arterial oxygensaturation/pulse oximetry (SpO2), the concentration or partial pressureof carbon dioxide in the respiratory gases, which is also known ascapnography, and so on. These signals can be further stored and/ortransmitted as patient data.

The medical device 400 also includes an alarm system 425 that functionsto generate an alarm under certain conditions. The alarm system 425includes a receiver such as a status detector 440 to accept statusinformation about the medical device 400 that includes the alarm system425. In some embodiments the status detector 425 includes a batterysensor 444 structured to determine a charge level of a battery in themedical device 400. In other embodiments the status detector 440includes a consumables ageing component 442 structured to determine ifan age of any consumable of the medical device 400 is beyond arespective expiration date. Consumables of the medical device 400 mayinclude pads, leads, batteries, etc., each of which may include aspecific and unique expiration date. In other embodiments the statusdetector 440 includes a maintenance schedule component 446 structured todetermine if the medical device 400 or components thereof is beyond aservice date. Service dates may include dates for software updates, forexample. In each of these examples, the status detector 440 may bestructured to determine that the medical device 400 is in the readystate when the particular component 442, 444, 446 satisfies its owncriteria. For example, the status detector 440 may determine that themedical device is in a ready state when the consumables ageing component442 determines that no age of any consumable of the medical device 400is beyond its respective expiration date. Similarly, the status detector440 may determine that the medical device 400 is in a ready state whenthe battery sensor 444 that a charging level of the medical device isabove a threshold level. Further, the status detector 440 may includeuser programmable settings 448 so that a user may set conditions forwhich the alarm system 425 would trigger an alarm to alert the user.When the user sets his or her own user programmable settings 448, thestatus detector 440 modifies the ready-state determination based on theuser programmable settings. Functions of the status detector 440 may beeffected by functions of a microprocessor of the medical device 400.

The alarm system 425 also includes a use detector 430 structured todetermine when the medical device is being prepared for use. For examplethe detector 430 may include a motion detector component 432 forgenerating a motion signal when the medical device is moved. The motiondetector 432 may be an accelerometer, for instance, that generates asignal when the medical device 400 is moved, for example when a rescuerpicks up the medical device 400 to take to a rescue scene. The usedetector 430 may also include a power detector component 434 structuredto generate a remove signal when the medical device is separated from apower source that is external to the medical device. In other words, ifthe medical device 400 is plugged into wall power, the power detectorcomponent 434 generates a signal when the medical device is unplugged,which may indicate that the medical device is being prepared for use.Functions of the use detector 430 may be effected by functions of amicroprocessor of the medical device 400.

In some embodiments the alarm system 425 may include its own powersupply 470, separate from any power supply on the medical device 400.

The alarm system 425 of the medical device 400 further includes an alarm450 that is activated when the medical device is both being prepared foruse and not in the ready state. For instance, the alarm system 425generates an alarm when the medical device 400 is unplugged, but whenpads associated with the medical device are beyond their use date. Thisgives the rescuer notice that he or she will need to replace the padsbefore the medical device 400 is properly ready for use. Providing suchan alarm 450 when it is detected that the medical device 400 is beingreadied for use is much better than those systems without alarms, inwhich case the rescuer may take the medical device into the field withinadequate equipment. The alarm 450 may be visible, audible, haptic, orany combination thereof. Additionally the audible alarm 450 may includevocalizing at least one word, which may be a word or words of caution ora warning. The audible alarm may present vocally to the user the reasonsfor which the alarm 450 is activated.

The alarm system 425 may include a user interface 460 including a userinput for causing the use detector 430 to determine that the medicaldevice is being prepared for use in response to receiving a manuallygenerated input at the user input. FIG. 5, for example, illustrates anexample user interface 560. The user interface 560 includes a screen 570on which information may be displayed. 5. The screen 570 may be used tocommunicate one or more reasons that caused the alarm 450 to beactivated. For example the screen 570 may display text or symbols forcommunicating to the user. The user interface 560 also includes anaudible interface such as a speaker 580, which may produce sounds orvoice commands for the user of the medical device 400, such as thosedescribed above.

FIG. 6 illustrates another example user interface 660, which may be anembodiment of the user interface 460 of FIG. 4. The user interface 660of FIG. 6 includes a screen 670 and speaker 680, similar to the userinterface 560 of FIG. 5. The user interface 660 includes furtherfeatures for user interaction, however. Indicators 630, 632, 634, and636 may illustrate a status of the medical device 400. For example, whenthe alarm system 425 determines that the device is about to be used andthe battery level has an insufficient charge, an alarm may sound fromthe speaker 680 and the indicator 630 turns on or flashes to inform theuser that the medical device is not in a ready state. The indicator 632generates a signal when one or more of the consumables of the medicaldevice 400 have expired or are nearing expiration. The indicator 634generates a signal when maintenance is overdue. Differently, theindicator 636 may generate a ready signal if the alarm system 425determines that the medical device is ready to be used and the medicaldevice 400 is, in fact, ready for use. For example the ready signal maybe generated through indicator 636 when the medical device 400 is readyto be used, the batteries are fully charged, the medical device hasup-to-date software, and all of the consumables are within their usableperiod.

The user interface 660 may include buttons for user feedback, such as abutton 650 that causes the alarm system to execute a self-test todetermine, if the medical device 400 were to be used, the condition ofthe medical device. A button 652 may allow the user to silence the alarm450 generated by the alarm system 425. In other embodiments the alarm450 may be automatically silenced after a pre-set time. In furtherembodiments the alarm 450 may be automatically re-armed after a timeduration.

Of course other user buttons, such as the user buttons 640, 642, 644, orfeedback signals may be included in the user interface 660. This mayallow the user to program certain desired functions into the medicaldevice, for example user programmable settings 448 for a particularsituation. In other embodiments the user programmable settings 448 maybe entered or modified using a setup facility 492, which may be coupledto the medical device 400 or alarm system 425 through a setup interfaceport 490 when needed. The setup facility 492 may be a program operatingon a computer coupled to the medical device 400.

FIG. 7 is a block diagram illustrating example components of an alarmsystem 700 that may be used to construct the alarm system 425 of FIG. 4according to embodiments. The alarm 700 may be formed on a circuitboard, for example, which may be coupled to or mounted within a medicaldevice. The alarm system 700 may be powered by a battery 750, which maybe a long-life user replaceable lithium coin cell, for example.

A processor 720 may be programmed to produce many or all of thefunctions of the alarm system 425 described above. Such programs may bestored in memory 724, for instance, or may be entered by use of a userinterface 760, or through a setup facility such as the setup facility492 of FIG. 4.

An alerting facility 740 may be used to perform the functions ofgenerating the alarm for the user. The alerting facility 740 may includegenerating signals for a user interface 760, which may be an example ofthe user interfaces 560, 660 described above. The alerting facility 740may also be embodied by a vibrating motor or piezoelectric buzzer, forexample. A motion sensor 712 may be embodied by an accelerometer orother appropriate device. A host interface 730 may receive signals ordata from the medical device to which the alarm system 700 is attached.The signals may be in analog or digital form.

Converters, such as an analog-to-digital converter 732 ordigital-to-analog converter 734 may be used to convert signals from onedomain to the other. Signals for conversion may include signals from themotion sensor 712 or signals received through the host interface 730,for instance, or for other signals used to help the alarm system 700operate properly.

FIG. 8 shows a flowchart 800 illustrating example methods for alerting auser of a medical device to a state of readiness of the medical deviceaccording to embodiments. According to an operation 802, an alarm systemdetermines if a medical device to which it is connected is about to beused. Sensing that the medical device is about to be used may includesensing that the medical device has moved, or may include sensing thatthe medical device has been separated from a power source external tothe medical device.

When the alarm system determines that the medical device is about to beused, an operation 804 assesses a value for a readiness state of themedical device. The value may be numeric or a Boolean value, forexample.

An operation 806 generates an alarm when the medical device is about tobe used and the assessed readiness state value is below a thresholdlevel. Assessing a value for a readiness state may include determiningan age of at least one consumable device used in association with themedical device, such as pads or batteries. The assessment may alsoinclude determining a charge level of the battery. The assessment mayalso include determining how recently the medical device has beenserviced or updated, such as by accessing a maintenance log of themedical device.

An optional operation 808 may output the cause of the alarm to the user.For example, the method may show the cause of the alarm on a display, ormay turn on an indicator light, for example. In another optionaloperation 810, the method outputs a ready signal when the medical deviceis about to be used and the medical device is at or above the thresholdlevel of readiness.

The threshold level used in operation 804 to compare to the readinessstate value of the medical device may be programmable and set by a user.The user may also be able to select factors that determine the readinessstate. Such factors may include, for example, battery power of themedical device, age of consumables to be used in conjunction with themedical device. Other factors may include a maintenance log of themedical device, or other indications of whether the medical device isup-to-date. For instance, the user may select which of the monitoredconditions will be used in the alarm analysis.

In this description, numerous details have been set forth in order toprovide a thorough understanding. In other instances, well-knownfeatures have not been described in detail in order to not obscureunnecessarily the description.

A person skilled in the art will be able to practice the presentinvention in view of this description, which is to be taken as a whole.The specific embodiments as disclosed and illustrated herein are not tobe considered in a limiting sense. Indeed, it should be readily apparentto those skilled in the art that what is described herein may bemodified in numerous ways. Such ways can include equivalents to what isdescribed herein. In addition, the invention may be practiced incombination with other systems.

The following claims define certain combinations and subcombinations ofelements, features, steps, and/or functions, which are regarded as noveland non-obvious. Additional claims for other combinations andsubcombinations may be presented in this or a related document.

In the claims appended herein, the applicant invokes 35 U.S.C. § 112,paragraph 6 only when the words “means for” or “steps for” are used inthe claim. If such words are not used in a claim, then the inventor doesnot intend for the claim to be construed to cover the correspondingstructure, material, or acts described herein (and equivalents thereof)in accordance with 35 U.S.C. § 112, paragraph 6.

What is claimed is:
 1. A medical device, comprising: a patient utilityconfigured to one or both of monitor a patient parameter and administera patient therapy; a status detector configured to determine a readinessstate of the medical device, the readiness state determined by one orboth of: detecting a component readiness state of at least one componentof the medical device, and detecting one or both of a device maintenancestatus of the medical device and a component maintenance status of atleast one component of the medical device; a use detector configured todetermine a change in a use status of the medical device, the use statusbased on sensing a transition of the medical device from a not-in-usecondition; and an indicator configured to be activated based on thereadiness state of the medical device and the change in the use statusof the medical device.
 2. The medical device of claim 1, wherein the atleast one component of the medical device is a consumable component andthe status detector includes a consumable aging component configured todetermine an age of the consumable component relative to an expirationdate associated with the consumable component, the status detectorcausing the readiness state of the medical device to indicate a notready state in response to the age of the consumable component exceedingthe expiration date.
 3. The medical device of claim 1, wherein thestatus detector includes a maintenance schedule component configured to:determine if one or both of the medical device and the at least onecomponent of the medical device exceeds a service date respectivelyassociated with the medical device and the at least one component of themedical device, wherein the status detector is further configured tocause the readiness state of the medical device to be a not ready statein response to one or both of the medical device or the at least onecomponent of the medical device exceeding a service date.
 4. The medicaldevice of claim 3, wherein the service date is associated with asoftware update of the medical device.
 5. The medical device of claim 1,wherein the status detector is configured to: receive the componentreadiness status of the at least one component of the medical device,and determine the component readiness status of the at least onecomponent of the medical device to be at least one of greater than athreshold value, less than a threshold value, and outside of thresholdrange.
 6. The medical device of claim 5, wherein the status detector isfurther configured to cause the readiness state of the medical device tobe a not ready state in response to the component readiness status beingat least one of greater than a threshold value, less than a thresholdvalue, and outside of a threshold range.
 7. The medical device of claim1, further comprising a user interface configured to accept user inputto configure at least one of the status detector or the indicator. 8.The medical device of claim 1, wherein the use detector includes amotion detector component configured to: generate a motion signal inresponse to the transition of the medical device from a not-in-usecondition, and cause the change in the use status of the medical device.9. The medical device of claim 1, wherein the use detector includes apower detector component configured to: generate a remove signal inresponse to the medical device separating from an external power source,and cause the change in the use status of the medical device.
 10. Themedical device of claim 1, wherein the not-in-use condition includes oneor both of an ideal condition and an at rest condition.
 11. The medicaldevice of claim 1, wherein the indicator includes an alarm.
 12. Themedical device of claim 1, wherein the indicator includes an output thatone or both of the medical device and a component of the medical devicerequires service.
 13. A medical device, comprising: a status detectorconfigured to determine a ready state or a non-ready state of themedical device based on: one or more of a component readiness status ofat least a component of the medical device, and a maintenance status ofat least one of the medical device or the at least a component of themedical device, a use detector configured to detect a change in a usestatus of the medical device based on determining a transition of themedical device from a not-in-use condition; and an indicator that isactivated based on the status detector determining the medical device isin the non-ready state and the use detector detecting the change in theuse status of the medical device.
 14. The medical device of claim 13,wherein the at least a component is a consumable component having anexpiration date and the status detector includes a consumables agingcomponent, the non-ready state determined based on a current date beinglater than the expiration date of the consumable.
 15. The medical deviceof claim 13, wherein the at least a component is a consumable componenthaving a usable age and a current age associated therewith, and thestatus detector includes a consumables aging component, the non-readystate determined based on the status detector determining that thecurrent age is greater than the usable age.
 16. The medical device ofclaim 13, wherein the status detector includes a maintenance schedulecomponent, the non-ready state determined based on the at least acomponent of the medical device or the medical device being beyond aservice date associated therewith.
 17. The medical device of claim 16,wherein the service date is associated with a software update.
 18. Themedical device of claim 13, wherein the change in the use status is notbased on a user supplied input to the medical device.
 19. The medicaldevice of claim 13, wherein the change in the use status is based on achange in one of a physical location, physical arrangement, or aphysical orientation of the medical device.
 20. The medical device ofclaim 13, wherein the not-in-use condition includes an idle condition oran at rest condition of the medical device.